BEUDAMED
    FDA Enforcement Class II Ongoing

    Hobbs Medical Polypectomy Snare, Catalog No. 7202

    Recall: Z-1388-2022 · Reported July 27, 2022

    Enforcement

    Recall Number
    Z-1388-2022
    Event ID
    90456
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hobbs Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2022
    Initiation Date
    June 3, 2022
    Classification Date
    July 15, 2022
    Address
    8 Spring St, N/A, Stafford Springs, CT, 06076-1505, United States

    Description

    Hobbs Medical Polypectomy Snare, Catalog No. 7202

    Reason

    During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.

    Code Info

    UDI-DI: M84972020 Package UDI: M84972021 Lots: H11-20-017 H04-20-062 H04-19-056 H11-19-077 H08-17-014R H10-17-089R H10-17-089 H0S-17-014 H06-17-167

    Distribution

    Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.

    Quantity

    45 (US)